Kornimate/medical-research-clean huggingface dataset:
investigation of the effectiveness of coronavac vaccine in cancer patients with active chemotherapy and comparison with healthy people.

Conditions: Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy

Summary: this study aimed to investigate the effectiveness of coronavac vaccine, which is more than 90% protective in healthy people, in cancer patients receiving active chemotherapy. in this study, to collect information to measure the amount of antibodies produced by the vaccine in the blood of volunteers with the coronovac vaccine and to compare it with healthy volunteers.


Eligibility criteria:
inclusion criteria: * group 1 1. 18 years old and above 2. having completed two doses of coronovac vaccine on time 3. those with a pathological diagnosis of breast cancer or lung cancer 4. being the first dose of vaccine during active chemotherapy period 5. ecog performance score 0-1 6. patients who signed the informed voluntary consent form * group 2 1. over 18 years old 2. ecog performance score is 0-1 3. those who have completed 2 doses of coronovac vaccine within the recommended period 4. volunteer who signed the informed consent form exclusion criteria: * for all groups 1. being confirmed or suspected covid-19 before vaccination 2. symptomatic covid-19 infection 3. being addicted to alcohol or drugs 4. having a fever of 37.8 ° c as a suspect before vaccination 5. aspleni

Keywords: coronovac covid-19
a placebo-controlled four way crossover study to asses the effect of a single oral dose of nktr-118 on qtc interval in healthy male subjects

Conditions: Amount of NKTR-118 in Blood; Variation in the Heart's Electrical Cycle

Summary: the purpose of this study is to evaluate the effects on qtc interval in healthy males when administered a single dose of nktr-118 compared with placebo and moxifloxacin. (qtc is a specific time interval that can be measured in a heart beat by taking electrocardiogram (ecg))

a single center, randomized, double-blinded, placebo-controlled, open-label, positive-controlled, four-way crossover study to assess the effect of a single oral dose nktr-118 administration on qtc interval compared to placebo, using avelox (moxifloxacin) as a positive control, in healthy male subjects

Eligibility criteria:
inclusion criteria: * healthy male subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * body mass index (bmi) between 18 and 30 kg/m2 (inclusive) and weight at least 50 kg but no more than 100 kg. exclusion criteria: * clinically significant medical history including severe allergies or a history of mental disorders or any cardiac history, history or presence of gastrointestinal, hepatic, or renal disease. * abnormal heart rhythm including any abnormal arrhythmias, marked sinus arrhythmias, or junctional rhythms. * known or suspected history of drug abuse, current smokers or those who have smoked and/or used nicotine products within 3 months prior to enrollment. * excessive intake of caffeine-containing products

Keywords: phase 1 healthy male volunteers cross-over study nktr-118
efficacy and safety of degarelix one month dosing regimen in korean patients with prostate cancer

Conditions: Prostate Cancer

Summary: this is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in korean patients with prostate cancer for bridging between cs21 trial (nct00295750) results.


Eligibility criteria:
inclusion criteria: * has given written informed consent before any trial-related activity is performed. * has a histologically confirmed (gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising psa after prostatectomy or radiotherapy) * is a male patient aged 18 years or older * has a screening serum testosterone level \>1.5 ng/ml * has an ecog (eastern cooperative oncology group) score of ≤ 2 * has a screening psa value of ≥2 ng/ml * has a life expectancy of at least 12 months exclusion criteria: * has had previous or is currently under hormonal management of prostate cancer. however, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to screening visit * is currently treated with a 5-α-reductase inhibitor * is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy * has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema * has hypersensitivity towards any component of the investigational medicinal product * a marked baseline prolongation of qt/qtcf interval * a history of additional risk factors for torsade de pointes ventricular arrhythmias * has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin * has a known or suspect hepatic, symptomatic biliary disease * has elevated serum alt level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the screening visit and confirmed with a second measurement within 21 days * has other clinically significant laboratory abnormalities * has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse * has a mental incapacity or language barriers precluding adequate understanding or co- operation * has received an investigational drug within the last 28 days preceding screening visit or longer if considered to possibly influence the outcome of the current trial * has previously participated in any degarelix trial
proton pump inhibitor treatment stop

Conditions: Dyspepsia

Summary: the purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. this is evaluated in a discontinuation trial.

background: testing patients with a helicobacter pylori (hp) 13c-urea breath test and treatment with eradication of hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. however, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (gord). this group of patients contributed to 59% of the total use of acid-suppressive medication in the county of funen in denmark in 1997. aim/purpose: it is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care. our secondary objective is to investigate the profile of symptoms, quality of life, hp-status, consumption of drugs and use of health care services in the same context. methods: to conduct a randomised, placebo-controlled, blinded, clinical discontinuation trial, 500 long-term users of acid-suppressive drugs are identified by general practitioners. long-term use is defined as treatment for more than 2x28 days during a 6-month period. the patients are included with a 13c-urea hp-breath test and randomised for treatment with ppi or placebo. hp-positive patients are treated with an hp-eradication treatment. the patients are followed for 1 year; the primary outcome is the need for open treatment with acid-suppressive medication due to failing symptom relief despite treatment with the randomised project medication. the patients are to fill in a symptom and medication diary every month for periods of 1 week. questionnaires are to be given to the patients 3 times during the follow-up period. medication diaries as well as questionnaires have proven useful in similar studies. the main outcome is analysed using kaplan-meier survival estimates analysis.

Eligibility criteria:
inclusion criteria: * use of antisecretory medication for more than 2 months during the last 6 months exclusion criteria: * malignity or severe, competing medical or psychiatric disease * esophagitis (proven by endoscopy) * prior complication to peptic ulcer disease * alarm symptoms * pregnancy or lactation * allergy towards esomeprazole * planned hospitalisation during study period

Keywords: dyspepsia discontinuation primary health care helicobacter pylori proton pump inhibitor histamine-2-receptor-antagonist
high dose baya1040_nifedipine: a long term combination study

Conditions: Hypertension

Summary: this is a clinical study evaluating the safety and efficacy of long term administration of oral baya1040_nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of baya1040_nifedipine 40 mg once daily and other antihypertensives.


Eligibility criteria:
inclusion criteria: * 20 years or older * japanese male or female * outpatient with essential hypertension * patients who are treated with adalat cr 40 mg od and at least one antihypertensive drug (other than ca antagonists) for 4 weeks or more before entry in this study exclusion criteria: * patients whose sitting diastolic blood pressure (dbp) is 110 mm hg or more * patients with secondary hypertension or hypertensive emergency

Keywords: baya1040 nifedipine essential hypertension japanese patients phase iii combination study 14024
observational cohort study evaluating the effectiveness of an educational program (ngaydautien) in combination with perindopril and amlodipine single-pill combination in hypertensive patients naïve of antihypertensive treatments.

Conditions: Hypertension

Summary: the primary objective is to assess the change of systolic blood pressure from baseline after a 6-month follow up for hypertensive patients initiating viacoram® plus an educational program (ngaydautien) in comparison to hypertensive patients initiating other antihypertensive drugs (except single pill combination).


Eligibility criteria:
inclusion criteria: 1. aged of at least 18 years (without upper limit of age) 2. diagnosis of grade 1 or grade 2 hypertension 3. naïve of treatment: * newly diagnosed hypertension and without treatment with antihypertensive effect for at least 3 months * previously diagnosed but without treatment with antihypertensive effect for at least 3 months 4. patients follow-up within the scope of the current medical practice and in the same health centre during the 6-month period exclusion criteria: 1. previously attended to the ngay dau tien educational program for hbp management 2. plan to be hospitalized for other medical conditions during the next 6 months 3. plan to move/relocate during 6-month follow-up 4. have a severe disease (i.e. cirrhosis, end-stage renal disease ...) 5. are unlikely to cooperate in the study 6. arm 1: patient having contra-indication to take viacoram® according to smpc 7. arm 2: patient showing interest in attending ndt educational program.

Keywords: observational blood pressure sbp dbp hypertension hbp hta viacoram® perindopril arginine and amlodipine patient educational program
role of oral steroid alone versus oral steroid plus intratympanic steroid injection in bell's palsy

Conditions: Bell Palsy

Summary: intratympanic steroid injection bell's palsy

role of oral steroid alone versus oral steroid plus intratympanic steroid injection in bell's palsy

Eligibility criteria:
inclusion criteria: * mean aged 18 years or more. * acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less. * moderate to severe facial palsy \[house-brackmann grade iv or greater\] exclusion criteria: * another cause of facial nerve paralysis that is not idiopathic. * otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected ramsay hunt syndrome. * systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy. * pregnancy
a pilot proof of concept study of the effects of administration of scfa in rheumatoid arthritis (easi-ra)

Conditions: Rheumatoid Arthritis

Summary: this study is a pilot, proof of concept study to determine the effects of administering an oral short chain fatty acid (scfa) supplement along with methotrexate as first line treatment of new onset rheumatoid arthritis (nora) patients. up to 50 participants will be included to obtain a sample size of at least 16 participants taking the oral supplement. the study team hypothesizes that oral scfa will change the participants' gut microbiome and regulatory immune responses. clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 2 and 4 months with an optional 6-month time point. fecal microbiome will be analyzed. adaptive immune responses will be analyzed from participant blood samples.


Eligibility criteria:
inclusion criteria: 1. new diagnosis of rheumatoid arthritis (ra) (\<6 months) meeting 2010 acr/eular for ra 2. scheduled to begin treatment with methotrexate at any dose as standard medical care 3. able and willing to provide written informed consent prior to any study specific procedures 4. age 18 years and above at time of enrollment 5. subjects not excluded based on race or ethnicity exclusion criteria: 1. participants who are pregnant or are currently breastfeeding 2. history of sensitivity to study compound or any of their excipients 3. previous intolerance to scfa or related compounds 4. current (within 3 months of screening) treatment with csdmards 5. current or past (ever) treatment with biologic therapies (including but not limited to anti-tnf, anti-il-17, anti-il-12/23) 6. current antibiotic treatment (within 3 months of screening) 7. current consumption of probiotics (within 3 months of screening) 8. severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) 9. renal failure (egfr \<30 or requiring dialysis) by history 10. history of other autoimmune disease 11. current immunodeficiency state (e.g., cancer, hiv, others)

Keywords: short chain fatty acid (scfa) butyrate gut microbiome
intensive arterial pressure control in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the intensive arterial pressure control in acute coronary syndrome (acs) during the first 24 hours can improve the prognosis in the short and long term. the study compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.

acute coronary syndrome is often associated with arterial pressure elevation which are deleterious for the heart and needs urgent intervention to lower the blood pressure to the required values, however there is no clear recommendations concerning the treatment intensity in this situation. the investigators know that high arterial pressure increases the oxygen myocardial consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce intensively this pressure.

Eligibility criteria:
inclusion criteria: * non-st segment elevation acute coronary syndrome exclusion criteria: * sbp under 90 mmhg or hemodynamic instability * complicated acs (arrythmias, atrio-ventricular block, shock, tamponade...) or st elevation myocardial infarction (stemi) * patients with contraindication to nitrates and/or beta blockers

Keywords: acute coronary syndrome, arterial pressure
harmonic focus versus conventional technique in total thyroidectomy for benign thyroid disease

Conditions: Benign Thyroid Disease

Summary: new haemostatic techniques have been developed with the advent of laparoscopic surgery. among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. previous studies in thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the harmonic device has been used. the aim of the present clinical trial is to evaluate potential advantages of a new harmonic device (focus), developed especially for thyroid procedures, in the use of hs in thyroidectomies when compared with ec in terms of operative time, number of ligatures, qol, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of rln palsy and hypoparathyroidism.

thyroidectomy is one of the most frequently performed operations in endocrine surgery. results are generally excellent, and morbidity and mortality are usually negligible. the operation requires proper identification of important structures such as the recurrent laryngeal nerve (rln) and the parathyroid glands. meticulous dissection and exhaustive hemostasis are important to ensure a dry field and to avoid inadvertent damage to the adjacent structures. the two most common techniques for hemostasis are suture ligatures and electrocoagulation. the use of electrocoagulation (ec) to control bleeding has the potential risk of injuring the surrounding structures from lateral dispersion of heat. new haemostatic techniques have been developed with the advent of laparoscopic surgery. among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. previous studies in thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the harmonic device has been used. the aim of the present clinical trial is to evaluate potential advantages of a new harmonic device (focus), developed especially for thyroid procedures, in the use of hs in thyroidectomies when compared with ec in terms of operative time, number of ligatures, qol, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of rln palsy and hypoparathyroidism.

Eligibility criteria:
inclusion criteria: * elected to undergo total thyroidectomy. * able to comprehend and sign the applicable study informed consent form. * able to return for all study mandated visits (visit 1 and 2) * be greater than or equal to 18 years of age. exclusion criteria: * previous neck operation * history of neck irritation * need for central or lateral compartment lymphadenectomy * patients under permanent pain killer medication * patients under anticoagulation medication

Keywords: consecutive euthyroid patients with multinodular goiter for whom a total thyroidectomy under general anesthesia is indicated
hospital to home study: trial to optimize transitions and address disparities in asthma care

Conditions: Asthma; Asthma in Children

Summary: caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. recruitment sites will be mainly children's national hospital sheikh zayed campus, as well as regional partners: holy cross hospital, and mary washington hospital. after enrollment, baseline data will be collected from caregiver. caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. control arm will receive the standard of care after hospital discharge. intervention arm will receive the soc plus an asthma navigator support after hospital discharge. caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.


Eligibility criteria:
inclusion criteria: 1. speak english or spanish 2. are at least 18 years old 3. live in the district of columbia, maryland, or virginia (dmv) 4. have a child aged 4-12 years who is hospitalized due to asthma exacerbation. exclusion criteria: 1. . children ages 4-12 years with chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder 2. . children ages 4-12 years involved in interventions with behavioral component and/or novel asthma therapeutics will be excluded given overlap with the current intervention 3. . children ages 4-12 years in foster care 4. . families not residing in the dmv 5. . caregivers who do not speak english or spanish

Keywords: asthma hospitalization children
effect of desmopressin on platelet function in ckd patients on antiplatelet drug

Conditions: Bleeding; Tachycardia; Dyspnea

Summary: prolonged collagen/epinephrine - closure time (cepi-ct) indicates platelet dysfunction in ckd patients taking antiplatelet agent. the synthetic vasopressin derivative, desmopressin (ddavp) shortens the prolonged bleeding time and improves platelet dysfunction measured by in vitro closure time: cepi-ct in uremic patients. desmopressin also antagonizes the in vitro platelet dysfunction induced by gpiib/iiia inhibitors, clopidogrel and aspirin. the investigators designed a prospective study to evaluate the effect of desmopressin on platelet function, as measured by in vitro collagen/epinephrine - closure time, in uremic patients who were taking antiplatelet drugs.


Eligibility criteria:
inclusion criteria: * adult uremic patients with one or more antiplatelet medication, * prolonged collagen/epinephrine (cepi) closure time, * need for emergent hemodialysis and * subsequent catheter insertion exclusion criteria: * acute coronary syndrome, * hemophilia, and nephrogenic diabetes insipidus, * allergy against desmopressin
noninvasive mapping before surgical ablation

Conditions: Atrial Fibrillation (AF)

Summary: the purpose of this study is to assess the electrophysiological mechanism of atrial fibrillation by means of a beat-to-beat noninvasive 3d mapping method in patients with concomitant persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.


Eligibility criteria:
inclusion criteria: * legal age (18-90a) * life expectancy \> 2 years * patients suffering from persistent and long standing atrial fibrillation * scheduled for concomitant surgical ablation * possibility to follow-up * given informed consent exclusion criteria: * vulnerable patient groups * pregnancy * any previous surgical ablation * acute surgical indications * any physical condition that leads to a life expectancy of less than two years * any contraindication to the treatments necessary for the trial's conduction as e.g. * known allergic reaction to contrast agent * known allergic reaction to antiarrhythmic drugs * claustrophobia or anxiety in small spaces * severe renal impairment * unmanageable hyperthyroidism * participation in any other clinical trial that either excludes enrolment or may be a confounding factor to results * voluntary retention

Keywords: atrial fibrillation electrocardiographic imaging noninvasive mapping surgical ablation